Ruling opens door for Noven’s oestrogen patch generics
In a victory for pharmaceutical company Amneal, a Delaware court has invalidated claims of three patents covering Noven Pharmaceuticals’ Minivelle oestrogen product.
In an opinion handed down on September 2 and made public on Friday, September 4, Chief Judge Leonard Stark, of the US District Court for the District of Delaware, found that the three patents were invalid for not meeting enablement and written description requirements.
Noven had sued Amneal back in May 2018, alleging infringement of US patent numbers 9,833,419; 9,730,900; and 9,724, 310. All of the patents, called “Transdermal estrogen device and delivery”, arise from the same original patent application or are continuations of it.
Minivelle is a Food and Drug Administration-approved oestrogen, which is used to treat moderate to severe vasomotor symptoms due to menopause. Amneal, which is seeking to market a bioequivalent version of Noven’s Minivelle product, asserted that it didn’t infringe the claims.
After a six-day trial was held over November 2019 and January 2020, Stark has now issued his 83-page ruling. In addition to finding that the patents are not valid, Stark also concluded that Amneal had infringed one of the patents.
“Amneal has shown, by clear and convincing evidence, that the patents fail to ‘convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the inventions’—here, a transmucosal patch system,” said Stark.
He concluded that the inventor didn’t provide a written declaration that would have demonstrated to a person skilled in the art that the inventor actually invented and possessed what he claimed.
The court also found that Amneal had proven that the patents failed to enable the claimed transmucosal estradiol (one of three estrogen hormones naturally produced in the body) patch systems.
Stark noted that a person skilled in the art would require “undue experimentation” to make and use the claimed transmucosal embodiments.
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